BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3230228 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11862
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377860, LOT# V006486, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE INS SITE WAS PINCHED RECENTLY WHICH CAUSED SEVERE PAIN. A ¿CALL YOUR DOCTOR¿ ICON DISPLAYED ON THE PATIENT PROGRAMMER. THE WARNING SCREEN WAS NO LONGER PRESENT AND THE BATTERY LEVEL SEEMED FINE. THE STIMULATION DID NOT QUIET FEEL THE SAME, WAS NOT AS SMOOTH AND DID NOT COVER THE PAIN. SHE WAS NOT ABLE TO ADJUST THE RATE ANYMORE AND SHE STILL FELT THE SAME. IT WAS LATER REPORTED THAT THE PATIENT¿S SYSTEM WAS REMOVED. THE PATIENT WANTED AN MRI OF HER HAND. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS), LEADS AND EXTENSIONS WERE REMOVED IN (B)(6) 2007. THE SYSTEM WAS EXPLANTED DUE TO THE PATIENT BELIEVING THE INS HURTING OR BOTHERING HER. SHE WAS HAPPY WITH HER CURRENT PUMP. THE MANUFACTURING REPRESENTATIVE KNEW ALL THE COMPONENTS WERE EXPLANTED BECAUSE SHE HAD A SPINAL MRI A COUPLE MONTHS PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329808 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention